{"entity":{"id":"panku-esophagus01","kind":"trial","name":"PANKU-Esophagus01 (BL-B01D1-305)","aka":[],"tldr":"The first bispecific ADC to extend both progression-free and overall survival in oesophageal cancer, for patients whose immunotherapy has stopped working.","summary":"Interim analysis met dual primary endpoints of OS and BICR-assessed PFS (announced February 2026; presented ASCO 2026). 249 vs 248 patients. Second-line ESCC previously had only single-agent chemotherapy (irinotecan, taxanes) with median OS under a year. Global confirmatory trials are being planned.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT06304974","url":"https://clinicaltrials.gov/study/NCT06304974"},{"label":"Announcement","url":"https://www.biospace.com/press-releases/izalontamab-brengitecan-iza-bren-demonstrates-statistically-significant-and-clinically-meaningful-improvements-in-overall-survival-and-progression-free-survival-in-patients-with-triple-negative-breast-cancer-and-esophageal-squamous-cell-carcinoma"}],"tags":[],"related":[],"cancers":["esophageal"],"sections":[],"technologies":["bispecific-adc"],"targets":["egfr","her3"],"drugs":["izalontamab-brengitecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["bl-b01d1-307"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06304974","phase":"3","setting":"Recurrent or metastatic oesophageal squamous cell carcinoma after PD-(L)1 inhibitor plus platinum chemotherapy: izalontamab brengitecan vs chemotherapy of physician's choice","sponsor":"SystImmune / BMS","result":"OS and PFS significantly improved at interim analysis; numbers per ASCO 2026 presentation.","started":"2024-03-19","startedType":"actual","yearReported":2026,"enrolled":497,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Izalontamab brengitecan","value":9.8},{"name":"Chemotherapy (physician's choice)","value":7.2}],"hr":0.64,"ci":[0.49,0.83],"p":"0.0004","source":"https://www.prnewswire.com/news-releases/systimmune-announces-second-approval-of-iza-bren-in-china-for-the-treatment-of-recurrent-or-metastatic-esophageal-squamous-cell-carcinoma-302827983.html"},{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Izalontamab brengitecan","value":4.2},{"name":"Chemotherapy (physician's choice)","value":2}],"hr":0.5,"ci":[0.4,0.63],"p":"<0.0001","source":"https://www.prnewswire.com/news-releases/systimmune-announces-second-approval-of-iza-bren-in-china-for-the-treatment-of-recurrent-or-metastatic-esophageal-squamous-cell-carcinoma-302827983.html"}],"replication":"Single Chinese phase 3 (ASCO 2026 oral; NMPA approval July 2026); consistent with the positive iza-bren phase 3s in nasopharyngeal carcinoma and TNBC (BL-B01D1-307). No data outside China yet."},"route":"/trials/panku-esophagus01/","neighbours":{"cancer":[{"id":"esophageal","kind":"cancer","name":"Oesophageal cancer","route":"/cancers/esophageal/"}],"technology":[{"id":"bispecific-adc","kind":"technology","name":"Bispecific ADC","route":"/technologies/bispecific-adc/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"},{"id":"her3","kind":"target","name":"HER3","route":"/targets/her3/"}],"drug":[{"id":"izalontamab-brengitecan","kind":"drug","name":"Izalontamab brengitecan","route":"/drugs/izalontamab-brengitecan/"}],"trial":[{"id":"bl-b01d1-307","kind":"trial","name":"BL-B01D1-307","route":"/trials/bl-b01d1-307/"}]}}